Ultravate is a drug owned by Mical Pharmaceuticals Llc-h Series. It is protected by 1 US drug patent filed in 2015 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 19, 2033. Details of Ultravate's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8962028 | Topical steroid composition and method |
Jun, 2033
(8 years from now) | Active |
FDA has granted several exclusivities to Ultravate. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ultravate, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Ultravate.
Exclusivity Information
Ultravate holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Ultravate's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 06, 2018 |
| New Patient Population(NPP) | Aug 31, 2023 |
US patents provide insights into the exclusivity only within the United States, but Ultravate is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Ultravate's family patents as well as insights into ongoing legal events on those patents.
Ultravate's family patents
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Generic Launch
Generic Release Date:
Ultravate's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 19, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ultravate Generics:
Halobetasol Propionate is the generic name for the brand Ultravate. 6 different companies have already filed for the generic of Ultravate, with Padagis Israel having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Ultravate's generic
How can I launch a generic of Ultravate before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ultravate's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ultravate's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ultravate -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 24 Jan, 2018 | 1 | 04 Jun, 2020 | 19 Jun, 2033 | Eligible |
About Ultravate
Ultravate is a drug owned by Mical Pharmaceuticals Llc-H Series. It is used for treating corticosteroid-responsive dermatoses, including psoriasis. Ultravate uses Halobetasol Propionate as an active ingredient. Ultravate was launched by Mical Pharms in 2015.
Market Authorisation Date:
Ultravate was approved by FDA for market use on 06 November, 2015.
Active Ingredient:
Ultravate uses Halobetasol Propionate as the active ingredient. Check out other Drugs and Companies using Halobetasol Propionate ingredient
Treatment:
Ultravate is used for treating corticosteroid-responsive dermatoses, including psoriasis.
Dosage:
Ultravate is available in lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.05% | LOTION | Discontinued | TOPICAL |